- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04766996
PROUD Study - Preventing Opioid Use Disorders
Study Overview
Status
Conditions
Intervention / Treatment
- Behavioral: Guided mindfulness exercises
- Other: Self-administered aromatherapy
- Drug: Baby aspirin
- Drug: Tylenol/Acetaminophen
- Drug: Pregabalin
- Drug: Prednisone
- Drug: Meloxicam
- Drug: Prilosec
- Drug: Tramadol
- Drug: Voltaren
- Drug: Zofran
- Drug: Pepcid
- Drug: Reglan
- Drug: Versed
- Drug: Lidocaine
- Drug: Propofol
- Drug: Ancef
- Drug: Tranexamic Acid (TXA)
- Drug: Decadron
- Drug: Bupivacaine hydrochloride
- Drug: Toradol
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University Orthopaedic and Spine Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria Intervention group:
- Prospective study participants undergoing unilateral total hip replacement surgery between the months of February through May, 2021
Inclusion Criteria Control:
- Retrospective controls selected from the Emory Healthcare System Clinical Data Warehouse that underwent unilateral total hip replacement surgery between the months of February through May, 2020
Inclusion Criteria Professional Staff:
- All staff that participate in the implementation of the opioid free surgical protocol.
Exclusion Criteria:
- Participants that do not speak English will not be eligible for participation in the study.
- Individuals less than 18 years of age will not be included for participation in the study.
- Individuals with cognitive impairment or the inability to provide informed consent will not be included in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prospective cases undergoing non-opioid drug regimen
Prospective study participants undergoing unilateral total hip replacement surgery and non-opioid drug regimen perioperatively
|
Guided Meditation twice daily
Self-administered aromatherapy every 6 hours and at bedtime
Baby aspirin 81mg: Twice daily for 6 weeks after surgery
Tylenol/Acetaminophen 1000mg: Pre-operative one dose; Every 8 hours for three weeks after surgery
Pregabalin 25mg: Twice a day for two weeks before surgery; Pre-operative 25-100 mg; Twice a day for two weeks after surgery
Prednisone 5mg: Daily for three weeks after surgery
Meloxicam 7.5mg: Twice a day, with food, for two weeks before surgery; Twice a day, with food, for two weeks after surgery Prilosec 20mg: Daily for two weeks before surgery; Daily for for two weeks after surgery
Rescue pain medicine Tramadol 50mg up to three times a day as needed will be provided for rescue pain
Voltaren 1% topical arthritis gel up to 4 times daily pre-operative only
Zofran 4 mg pre-operative
Pepcid 20 mg pre-operative
Reglan 10 mg pre-operative
Versed 2 mg pre-operative
Lidocaine (preservative free) height based dosing for subarachnoid block intraoperatively
Propofol 10-125 mcg/kg/min intraoperative
Ancef 2-3 gm weight-based dosing intraoperative
Tranexamic Acid (TXA) 2 gm intraoperative
Decadron 10 mg intraoperative
Local anaesthetic 0.5% bupivacaine hydrochloride intraoperative
Toradol nonsteroidal anti-inflammatory drug max 30 mg intraoperative
|
No Intervention: Retrospective control underwent opioid drug regimen
Retrospective controls that underwent unilateral total hip replacement surgery and used opioid drug regimen perioperatively
|
|
No Intervention: Professional Staff
Staff that participate in the implementation of the opioid free surgical protocol will be completing team assessment surveys seeking their opinion about interprofessional teamwork and communication.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Post-operative Opioid Requirements With Non-opioid Drug Regimen
Time Frame: Up to 5 weeks
|
Total post-operative opioid requirements (opioid dose) were calculated for participants receiving the non-opioid drug regimen, among participants who required post-operative opioid medication.
|
Up to 5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nebraska Interprofessional Education Attitude Scale (NIPEAS) Score for Professional Staff Arm
Time Frame: Prior to protocol implementation (baseline), halfway through the recruitment period (2 months) and after the last participant has been discharged from the hospital (4 months)
|
The Nebraska Interprofessional Education Attitude Scale (NIPEAS) was developed to measure the attitudes of pre-clinical learners to practicing health professionals.
The NIPEAS is a 19-item questionnaire assessing attitudes related to interprofessional collaboration.
Responses were given using a 5-point Likert scale where 1 = Strongly Disagree to 5 = Strongly Agree.
The total score is the average of the average scores for each item and ranges from 1 to 5. A higher total score indicates increased positive perceptions toward interprofessional collaboration.
|
Prior to protocol implementation (baseline), halfway through the recruitment period (2 months) and after the last participant has been discharged from the hospital (4 months)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wiltse Nicely, PhD, CRNA, Emory University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Antineoplastic Agents
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Analgesics, Opioid
- Narcotics
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Hypnotics and Sedatives
- Anti-Anxiety Agents
- Anticonvulsants
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Calcium-Regulating Hormones and Agents
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Cyclooxygenase 2 Inhibitors
- Calcium Channel Blockers
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Aspirin
- Propofol
- Lidocaine
- Acetaminophen
- Prednisone
- Pregabalin
- Tranexamic Acid
- Bupivacaine
- Diclofenac
- Tramadol
- Omeprazole
- Ketorolac Tromethamine
- Meloxicam
Other Study ID Numbers
- STUDY00002021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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